Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00888901
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2009-04-27
Brief Title:
Platelet Function in Idiopathic Thrombocytopenic Purpura ITP Patients With Eltrombopag
Sponsor:
Ingrid Pabinger MD
Organization:
Medical University of Vienna
Study Overview
Official Title:
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura cAITP Treated With the Thrombopoietin Receptor MPL Agonist Eltrombopag
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATEFUN
Brief Summary:
This is a single-center prospective controlled study with one eltrombopag treatment group and 2 control groups one on standard steroid treatment and another one untreated
The aim of the study is to determine the effect of Thrombopoietin Receptor MPL agonists on shear-induced platelet activation
The aim of the study is to determine the effect of Thrombopoietin Receptor MPL agonists on shear-induced platelet activation
Detailed Description:
STUDY DESIGN
Single-center Medical University Vienna prospective controlled study Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna one eltrombopag treatment group and 2 control groups one on standard steroid treatment another one untreated
AIM OF THE STUDY
To determine the effect of MPL agonists on shear-induced platelet activation Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag
PATIENTS
Trial Population
Total number of patients n34 12 on eltrombopag 12 on corticosteroids and 10 without treatment will be included in this trial
Treatment with eltrombopag or corticosteroids Eltrombopag starting dose 25 mgday increased as needed to 50 mg or maximum 75 mg once daily every 2 weeks to reach a platelet count between 50000-100000µL and tapering the dosis if platelet count 100000µL Afterwards if platelet count stable tolerance - 20 platelet control every 4 weeks otherwise weekly
Prednisolone starting dose 1 mgkgday to reach a platelet count between 50000-100000 µL tapering of the dosage if platelet count 100000µL
Laboratory Investigations
In the eltrombopag group and in the newly treated prednisolone group platelet counts and platelet function tests will be performed at planned visits
In patients who are on continuous corticosteroids part of control group I and untreated patients control group II which have a platelet count between 50000 and 100000µL platelet counts reticulated platelets platelet function tests and platelet antibodies will be studied at entry and after 4 weeks 5 days
Single-center Medical University Vienna prospective controlled study Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna one eltrombopag treatment group and 2 control groups one on standard steroid treatment another one untreated
AIM OF THE STUDY
To determine the effect of MPL agonists on shear-induced platelet activation Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag
PATIENTS
Trial Population
Total number of patients n34 12 on eltrombopag 12 on corticosteroids and 10 without treatment will be included in this trial
Treatment with eltrombopag or corticosteroids Eltrombopag starting dose 25 mgday increased as needed to 50 mg or maximum 75 mg once daily every 2 weeks to reach a platelet count between 50000-100000µL and tapering the dosis if platelet count 100000µL Afterwards if platelet count stable tolerance - 20 platelet control every 4 weeks otherwise weekly
Prednisolone starting dose 1 mgkgday to reach a platelet count between 50000-100000 µL tapering of the dosage if platelet count 100000µL
Laboratory Investigations
In the eltrombopag group and in the newly treated prednisolone group platelet counts and platelet function tests will be performed at planned visits
In patients who are on continuous corticosteroids part of control group I and untreated patients control group II which have a platelet count between 50000 and 100000µL platelet counts reticulated platelets platelet function tests and platelet antibodies will be studied at entry and after 4 weeks 5 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eltrombopag 112650 | None | None | None |